FDA.reportPublic FDA data

Portable Parallel Bars

Primary DI
00854798000786
Brand
Portable Parallel Bars
Company
PIVOTAL HEALTH SOLUTIONS, INC.
Model
PTPB-1000
Published
2026-03-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IOEBars, Parallel, Exercise

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IOEBars, Parallel, ExercisePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854798000786PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854798000786008547980007868547980007860854798000786

GMDN Terms#

Term, Definition table
TermDefinition
Parallel bar exerciser, non-poweredAn exercise apparatus designed to assist users in maintaining good walking posture, particularly a person with a disability, a paraplegic, or a patient who has suffered a stroke and is learning to walk. It typically consists of two parallel wooden or steel handrails each one supported by two poles and base plates; the user holds the bars, which may be manually height and width-adjustable, thus relieving his/her weight when walking. The device is intended to improve the user?s balance as well as coordination and flexibility; additionally, it can improve the muscle strength in the lower limbs.

Regulatory Flags#

DUNS number
826316098
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854798000793Torque TableTT10002026-05-27
00854798000526Elevating Hand Therapy TableHT1002026-03-27
00854798000533Elevating Hand Therapy TableHT2002026-03-27
00854798000571Elevating Hand Therapy TableHT9002026-03-27
00854798000588Elevating Hand Therapy TableHT17002026-03-27
00854798000601Elevating Hand Therapy TableHT19002026-03-27
00854798000656Elevating Hand Therapy TableREV1002026-03-27
00854798000663Elevating Hand Therapy TableREV2002026-03-27
00854798000670Elevating Hand Therapy TableREV9002026-03-27
00854798000748Elevating Hand Therapy TableREV17002026-03-27
00854798000762Elevating Hand Therapy TableREV19002026-03-27
00854798000465Parallel Bars Electric Platform MountEPB10080-NE2026-01-22
00854798000472Parallel Bars Electric Platform MountEPB10080B-NE2026-01-22
00854798000489Parallel Bars Electric Platform MountEPB10010-NE2026-01-22
00854798000496Parallel Bars Electric Platform MountEPB10010B-NE2026-01-22
00854798000502Parallel Bars Electric Platform MountEPB10012-NE2026-01-22
00854798000519Parallel Bars Electric Platform MountEPB10012B-NE2026-01-22
00850020142446AE Elevating Treatment TableA4201-EL2025-08-12
00854798000298Parallel Bars Electric Platform MountEPB100802025-05-09
00854798000311Parallel Bars Electric Platform MountEPB100102025-05-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00849229006154MJM THERAPY REHAB WEIGHTED BARM J M International CorporationIOE2023-07-31
00849229006161MJM THERAPY REHAB WEIGHTED BARM J M International CorporationIOE2023-07-31
00849229006178MJM THERAPY REHAB WEIGHTED BARM J M International CorporationIOE2023-07-31
00849229006185MJM THERAPY REHAB WEIGHTED BARM J M International CorporationIOE2023-07-31
00849229006192MJM THERAPY REHAB WEIGHTED BARM J M International CorporationIOE2023-07-31
00849229006208MJM THERAPY REHAB WEIGHTED BARM J M International CorporationIOE2023-07-31
00849229006215MJM THERAPY REHAB WEIGHTED BARM J M International CorporationIOE2023-07-31
00849229006222MJM THERAPY REHAB WEIGHTED BARM J M International CorporationIOE2023-07-31
00849229006239MJM THERAPY REHAB WEIGHTED BARM J M International CorporationIOE2023-07-31
00849229006246MJM THERAPY REHAB WEIGHTED BARM J M International CorporationIOE2023-07-31
00849229006253MJM THERAPY REHAB WEIGHTED BARM J M International CorporationIOE2023-07-31
00849229006260MJM THERAPY REHAB WEIGHTED BARM J M International CorporationIOE2023-07-31
00849229006277MJM THERAPY REHAB WEIGHTED BARM J M International CorporationIOE2023-07-31
00849229006284MJM THERAPY REHAB WEIGTHED BARM J M International CorporationIOE2023-07-31
00849229006291MJM THERAPY REHAB WEIGTHED BARM J M International CorporationIOE2023-07-31
00849229006307MJM THERAPY REAHB WEIGHTED BARM J M International CorporationIOE2023-07-31
00849229006314MJM THERAPY REHAB WEIGHTED BARM J M International CorporationIOE2023-07-31
00849229006321MJM THERAPY REHAB WEIGHTED BARM J M International CorporationIOE2023-07-31
00849229006338MJM THERAPY REHAB WEIGHTED BARM J M International CorporationIOE2023-07-31
00849229006345MJM THERAPY REHAB WEIGHTED BARM J M International CorporationIOE2023-07-31
B866MAM7131ARMEDICAARMEDICA MANUFACTURING CORP.IOE2023-05-26
B866PAM7131ARMEDICAARMEDICA MANUFACTURING CORP.IOE2023-05-26
B866MAM7071ARMEDICAARMEDICA MANUFACTURING CORP.IOE2022-11-18
B866MAM7081ARMEDICAARMEDICA MANUFACTURING CORP.IOE2022-11-18
B866MAM7091ARMEDICAARMEDICA MANUFACTURING CORP.IOE2022-11-18
B866MAM7101ARMEDICAARMEDICA MANUFACTURING CORP.IOE2022-11-18
B866MAM7111ARMEDICAARMEDICA MANUFACTURING CORP.IOE2022-11-18
B866MAM7121ARMEDICAARMEDICA MANUFACTURING CORP.IOE2022-11-18
B866MAMTM7001ARMEDICAARMEDICA MANUFACTURING CORP.IOE2022-11-18
B866MAMTM7021ARMEDICAARMEDICA MANUFACTURING CORP.IOE2022-11-18